Right off the bat:
- You can’t have a single product with two commercial names in the same place, at the same time. BionTech hasn’t been erased. So there are two Pfizer products: Comirnaty and Pfizer-BionTech.
- Until the vial content is independently audited, we can’t know the difference between the two, because this info has been redacted from the publicly available letters.
But we know for sure there is one and it’s significant enough to earn a new commercial name. - (After four updates that I had to erase to clarify and make this more readable)
“BioNTech said it was developing four vaccine candidates under a programme named BNT162 with its partner, pharma giant Pfizer… BioNTech, which awarded the rights in China to BNT162 to Shanghai Fosun Pharmaceutical under a March collaboration deal…” – Reuters
In its press release, Pfizer maintains:
“The FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series. An individual may be offered either COMIRNATY® (COVID-19 Vaccine, mRNA) or the Pfizer-BioNTech COVID-19 Vaccine to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2.”
In the same press release, we find out the Comirnaty concoct is scientifically identified as BNT162b2. Like the afore-mentioned program BNT162, version ‘b2’.
It’s the same one as in the US EUA, so, officially, the EUA and the full approval (BLA) are awarded to the same formulation indeed, we can get that out of the way.
However, the European EUA doesn’t mention any of the formulation, so we cannot know what they used there. A German government website does mention b2, EMA (the European FDA) doesn’t anywhere, or I haven’t found it yet.
Let’s have a look at ‘b1’:
COVID-19 vaccine BNT162b1 elicits human antibody and T H 1 T cell responses
And here we find out that serial number corresponds to the lipid naono-particles formulations. So e found at least two different formulations:
Phase I/II study of COVID-19 RNA vaccine BNT162b1 in adults
The full approval is for BNT162b2.
Well, CDC is the one to bring clarity this time:
https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2020-08/Pfizer-COVID-19-vaccine-ACIP-presentation-508.pdf
Confirmed: they had four formulations, they picked b2 version but they interchanged and cherry-picked the trial data as needed: they licensed b2 in US based on German trials made with b1 and so forth.
And when you think “this is it”, it’s never it:
Looks like FDA itself picked b2 and knew the trial data is mixed up between formulations, had no problem with it, more so, I discovered there were even more versions used in trials, such as b3c and so forth. Don’t believe me, check page 15 in this FDA document (PDF), as pictured at the top of the article!
One question remains: Comirnaty as commercial name has long been used in EU, maybe not much in ads or mainstream media for decerebrated plebs, but in anything more technical than that. Why not in US, if they used the same formulation?
Symmetrically, EU used the name, but no so sure about the b2 formulation.
And after all this, no one can be certain what formulation they actually put in the vials. - Cominarty has been approved based on only two trial studies that end 2023. It has about a dozen more to complete, as stated in the letter. I don’t see how that can be legal, but if it is, the data can change by the end of the studies, at least theoretically, which means the legal basis for the approval may very well evaporate.
In a sane world, the Pfizer approval blunder would be the medical equivalent of the Afghanistan ‘blunder’.
Forget about informed consent, safety, data… all they have is more guns. Which brings me to… - The US Government, like most others, has left legality in March 2020 and not governing. There are dozens of known old meds that can treat these respiratory problems labeled as Covid, more are screened and discovered, there was no evidence of a new virus, at least at the time when they introduced the Emergency state. So the Emergency, the government instating it and everything that started with it is illegal and an act of terrorism. So US doesn’t have a government, but a terrorist organization holding it hostage. Nothing they did after March 2020 is remotely legal, both Trump and Biden should stand in the accused box at Nuremberg 2 now. But sleepy ghosts are changing bed sides dreaming they wake up as people who still hold a little control over their lives.
In fact, all this is held together solely by the gun, military superiority, and psychological abuse, legal talk is 200% off and it’s just deepening the mass-hypnosis.
There is no law but the gun, if the government didn’t have a laser point on each forehead, it wouldn’t even exist at this point.
It’s bare war.
If you’re not ready to internalize reality, you are not ready to change it. - What the cover pic says. Then check this out!
Marion. F. Gruber, PhD
Director, Office of Vaccines Research & Review
FDA/CBER
10903 New Hampshire Ave, Building 71, Rm. 3230
Silver Spring, Maryland 20993, USA
Tel: + 1 301 796 1856
e-mail: marion.gruber@fda.hhs.gov
UPDATE SEPT 2, 2021:
THE FDA GRUBER RESIGNS LEAVING THE PFIZER GRUBER ORPHANED
I BET MY ASS SHE’S AVOIDING RESPONSIBILITY FOR THE WAY SHE HAS OVERSEEN THE PFIZER APPROVALS
CHD reports:
<<Two of the U.S. Food and Drug Administration’s (FDA) top vaccine regulators will leave the agency this fall, raising questions about the Biden administration and the way it sidelined the agency.
According to an email sent by Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER), to staff members Tuesday, Dr. Marion Gruber, director of the FDA’s vaccines office, will quit at the end of October, and her deputy, Dr. Philip Krause, will leave in November.
Gruber and Krause were upset about the Biden administration’s recent announcement that adults should get a COVID booster eight months after they received a second shot, people familiar with the decision told The New York Times.
Neither believed there was enough data to justify offering booster shots yet, the sources said, and both viewed the announcement, amplified by President Biden, as pressure on the FDA to quickly authorize them.
Officials within the FDA were stunned by the news, CNN reported. One source described it as a “big loss” for the FDA and noted it caught leadership off guard.ORDER TODAY: Robert F. Kennedy, Jr.’s New Book — ‘The Real Anthony Fauci’
Marks said he would serve as the acting director of the vaccines office while the agency searched for its next leader.
FDA Spokeswoman Stephanie Caccomo said the agency was “confident in the expertise and ability of our staff to continue our critical public health work.”
However, a former senior FDA leader told Endpoints News, Gruber and Krause are departing because they’re frustrated the Centers for Disease Control and Prevention (CDC) and its advisory panel — the Advisory Committee on Immunizations and Practices (ACIP) — are involved in decisions they think should be up to the FDA.
The source said he heard Gruber and Krause were upset with Marks for not insisting those decisions be kept inside the FDA, and with the White House for getting ahead of FDA on booster shots.
“These two are the leaders for biologic [vaccine] review in the U.S.,” wrote Rick Bright, former director of the Biomedical Advanced Research and Development Authority, weighing in on the news. “They have a great team, but these two are the true leaders of CBER. A huge global loss if they both leave,” Bright said.
“Dr. Gruber is much more than the director,” Bright added. “She is a global leader. Visionary mastermind behind global clinical regulatory science for flu, Ebola, Mers, Zika, Sars-CoV-2, many others.”>>
Anyone who thinks she sweated harder than Trump for Pfizer’s approval, but all of a sudden had a change of mind and decided to sabotage the boosters is a baby. She’s hiding from justice.
I hope this helped, if anything, I’ll add it here.
To be continued?
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